BioTalent is partnered with a fast-growing device manufacturer as they dive into the IVD market to find a strong.You will get to drive regulatory changes throughout new and existing product lines t...Show moreLast updated: 21 days ago
Promoted
OUTREACH MANAGER - ELDER AFFAIRS
Town of CohassetMA, United States
$32.62 hourly
Full-time
The Town of Cohasset, an active waterfront community on the South Shore, is looking for an Outreach Manager for our Elder Affairs Department.
The team at the Town of Cohasset is known for being dyna...Show moreLast updated: 1 day ago
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GRADUATE STUDENT AFFAIRS COORD
Harvard UniversityMA, United States
$40.00 hourly
Full-time
Three or more years of experience in office administration or related field (business environment and / or customer service).
Education beyond high school may count toward experience.Additional Qualif...Show moreLast updated: 1 day ago
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New!
Vice President / Global Head, Regulatory Affairs
CardurionBurlington, MA, US
Full-time
Vice President / Global Head, Regulatory Affairs.Vice President / Global Head, Regulatory Affairs.This role is either Hybrid in Burlington, MA or Remote.
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CVS HealthWork from home, MA, US
Remote
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Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health.
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Medical Director, Medical Affairs
VeristatMassachusetts
$150,000.00–$180,000.00 yearly
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Parexel International CorporationBillerica, MA, United States
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SR GLOBAL REGULATORY AFFAIRS ECTD PUBLISHING ASSOCIATE
Fresenius Medical CareMA, United States
Full-time
If your location allows for pay / benefit transparency, please click the link below to request further information on this position.
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LifelancerMassachusetts, Massachusetts, United States
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Remote
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Quick Apply
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BioPharma Consulting JAD GroupMA, United States
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Cardurion Pharmaceuticals, IncBurlington, MA, US
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Deciphera PharmaceuticalsMA, United States
Full-time
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MEDICAL ASSISTANT
Carbon HealthMA, United States
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Takeda Pharmaceutical Company LimitedMA, United States
$149,100.00–$234,300.00 yearly
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By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Taked...Show moreLast updated: 3 days ago
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New!
VP MEDICAL AFFAIRS NEURO-RARE - REMOTE OPPORTUNITY
LundbeckMA, United States
Full-time
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ASSISTANT PROVOST FOR GRADUATE AFFAIRS, ASSOCIATE PROVOST FOR GRADUATE AFFAIRS
Boston UniversityMA, United States
Full-time
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SUNY College of OptometryMA, United States
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VP, Quality & Regulatory Affairs
OSI Systems, IncAndover, Massachusetts
Rapiscan Systems is an industry leader in detection technology, providing cargo and vehicle inspection systems and services for ports, borders, military, high-threat facilities, and checkpoints to ...Show moreLast updated: 30+ days ago
BioTalent is partnered with a fast-growing device manufacturer as they dive into the IVD market to find a strong Regulatory Affairs Manager to join their ranks. You will get to drive regulatory changes throughout new and existing product lines to align with both FDA and EU regulations while showcasing your leadership skills to upper management.
Key Responsibilities :
Develop and implement regulatory strategies to facilitate timely approvals for new and existing products.
Manage global product registrations, licensing, and regulatory compliance across key markets.
Serve as the primary liaison with regulatory bodies, including the FDA, Notified Bodies, and international agencies.
Oversee the preparation and submission of regulatory documentation to ensure compliance with global standards.
Support regulatory compliance throughout the product lifecycle, including post-market surveillance activities.
Lead efforts to transition products from IVDD to IVDR compliance.
Collaborate with quality assurance teams to align regulatory and quality system requirements.
Guide and support the expansion of the Regulatory Affairs function, including hiring, training, and mentoring team members.
Manage external consultants, contractors, and regulatory support resources.
Foster a culture of compliance, quality, and continuous improvement across the organization.
Qualifications & Experience :
Minimum of 10 years of experience in regulatory affairs, particularly with Class I and Class II (IVDD / IVDR Class A / B / C) medical devices.
Strong knowledge of international regulatory frameworks, including MDSAP, EU IVD regulations, and global quality system standards.
Demonstrated expertise in preparing technical files and documentation for IVDR compliance.
Experience with global product registration processes across markets such as the US, Canada, Brazil, Japan, EU, Australia, and APAC.
Exceptional organizational, communication, and leadership skills.
Benefits for the Regulatory Affairs Manager
Hybrid work structure (3 days onsite, 2 from home).